JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Обзор

Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints. Patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).

Вмешательства

• Устройство Alto Abdominal Stent Graft System
  Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted.
• Устройство FDA Approved EVAR AAA Graft Systems
  FDA approved comparator of choice

Первичные конечные точки

• Number of Participants with Freedom from Aneurysm-Related Complications (ARC) [Срок оценки: Through 5 years]
• Neck Dilation in mm [Срок оценки: Through 5 years]

Вторичные конечные точки (12)

• Number of Major Adverse Events (MAEs) [Срок оценки: At 30 days and 12 months]
• Count of participants All Cause Mortality [Срок оценки: At 30 days, 12 months, and annually up to five years]
• Count of participants AAA-related Mortality [Срок оценки: At 30 days, 12 months, and annually up to five years]
• Number of Type Ia endoleaks [Срок оценки: At 30 days, 12 months, and annually up to five years]
• Number of Type Ib [Срок оценки: At 30 days, 12 months, and annually up to five years]
• Number of Type II [Срок оценки: At 30 days, 12 months, and annually up to five years]
• Number of Type III [Срок оценки: At 30 days, 12 months, and annually up to five years]
• Number of Type IV [Срок оценки: At 30 days, 12 months, and annually up to five years]
• Number of Unknown Enooleaks [Срок оценки: At 30 days, 12 months, and annually up to five years]
• Number of Secondary interventions [Срок оценки: At 30 days, 12 months, and annually up to five years]
• Count of subjects lacking device integrity [Срок оценки: At 30 days, 12 months, and annually up to five years]
• count of aneurysm ruptures [Срок оценки: At 30 days, 12 months, and annually up to five years]

Критерии участия

Критерии включения

• Adult age 21 and older
• Subjects with minimum of 2 year life expectancy
• Subjects have signed the informed consent document
• Subjects with unruptured infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.
• Patient must be able and willing to comply with all required follow-up exams.

Критерии исключения

• Currently participating in another trial where the primary endpoint has not been reached yet.
• Known allergy to any of the device components
• Pregnant (females of childbearing potential only)
• Known connective tissue disorders
• Known active infection
• Subjects with pre-existing EVAR, i.e., in need of repair/intervention of a previously failed EVAR.
• Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 29 центров

• Huntsville Hospital — Huntsville
• University of Arizona — Tucson
• Washington Regional Medical Center — Fayetteville
• Central Arkansas Veterans Healthcare System — Little Rock
• The Regents of the University of California, San Diego — La Jolla
• Veterans Affairs San Diego Healthcare System — San Diego
• MedStar Washington Hospital Center — Washington D.C.
• Jacksonville Center for Clinical Research — Jacksonville
• … и ещё 21 центр

Идентификаторы

NCT: NCT05064540 · CP-0017

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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